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Dense Red Blood Cells in Sickle Cell Children (DREPADENSE)

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ClinicalTrials.gov Identifier: NCT02887118
Recruitment Status : Terminated (The recruiting centre was no longer presenting new patients for inclusion)
First Posted : September 1, 2016
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Corinne Pondarré, Centre Hospitalier Intercommunal Creteil

Study Description
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Brief Summary:
Quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the Creteil pediatric cohort.

Condition or disease
Sickle Cell Disease

Detailed Description:

An association between red blood cell density and hemolytic parameters, and clinical manifestations has been demonstrated in adults with sickle cell anemia.

This factor has not been studied in children. The identification of predictive biomarkers of disease severity, especially of specific pediatric complications (cerebral vasculopathy, splenic sequestration, Dactylitis) would be useful for optimal care of the children and early intensification Red blood cell density might be one of these prognostic factors.

Study Design
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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort
Actual Study Start Date : December 2015
Actual Primary Completion Date : July 7, 2019
Actual Study Completion Date : July 7, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Common arm
Children with sickle cell anemia will be included. Blood samples of all the included patients will be collected during a day-hospitalization for a planned chek-up. For all these patients the number of dense erythrocytes will be evaluated


Outcome Measures
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Primary Outcome Measures :
  1. number of dense red blood cells (DRBC) [ Time Frame: 1 day ]
    Evaluation of the number of dense red blood cells in the blood of affected children


Secondary Outcome Measures :
  1. biological profile [ Time Frame: 1 day ]
    hemolytic parameters (LDH, bilirubin, Hemoglobin level)

  2. Number of patients with velocities > 200 cm/sec on transcranial doppler [ Time Frame: 1 day ]

    Cerebral vasculopathy (correlation with patients with abnormal velocities on transcranial doppler (TCD)(> 200 cm/sec)

    History of dactylitis History of ischemic lesions on magnetic resonance imaging (MRI)


  3. Number of patients with history of acute splenic sequestration, [ Time Frame: 1 day ]
  4. Number of patients with history of acute chest syndrome [ Time Frame: 1 day ]
  5. Number of patients with History of dactylitis [ Time Frame: 1 day ]
  6. Number of patients with history of abnormal transcranial doppler (TCD) (≥ 200 cm/sec) [ Time Frame: 1 day ]
  7. Number of patients with history of ischemic lesions on magnetic resonance imaging (MRI) [ Time Frame: 1 day ]
  8. Number of patients with hydroxycarbamide treatment [ Time Frame: 1 day ]
    effect of hydroxycarbamide on the % DRBC

  9. Number of dense red blood cells [ Time Frame: 1 day ]
    number of dense red blood cells in the pediatric population with no known blood condition


Biospecimen Retention:   Samples Without DNA
blood samples to study dense red blood cells

Eligibility Criteria
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Ages Eligible for Study:   18 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with sickle cell disease followed regularly in the CHI creteil hospital aged from 18 months to 18 years old.
Criteria

Inclusion Criteria:

  • Age: 18 months-18 years
  • Patient with sickle cell disease namely SS, or S / Beta0 or S / Beta +
  • Patient regularly followed in the pediatric cohort of the CHI Creteil
  • Patient Hospitalized for an annual check-up
  • With or without intensification by Hydroxycarbamide
  • patient who haven't been transfused within 3 months
  • Whose parents have given their informed consent
  • Patients insured to the French social scheme

Exclusion Criteria:

  • Sickle cell SC disease
  • Having received an allogeneic bone marrow transplantation
  • Under regular transfusion program
  • Having received a transfusion within 3 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887118


Locations
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France
CHI Creteil
Créteil, France, 94000
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Investigators
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Principal Investigator: Corinne Pondarre, MD PhD CHI Créteil
More Information
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Publications:

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Responsible Party: Corinne Pondarré, Doctor, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02887118    
Other Study ID Numbers: DREPADENSE
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Corinne Pondarré, Centre Hospitalier Intercommunal Creteil:
Erythrocytes
Sickle Cell Disease
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn